UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060590 |
|---|---|
| Receipt number | R000069157 |
| Scientific Title | Study on the Effects of Test Food Intake on Skin Function Improvement - Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial - |
| Date of disclosure of the study information | 2026/02/05 |
| Last modified on | 2026/02/03 17:50:52 |
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Basic information
Public title
Study on the Effects of Test Food Intake on Skin Function Improvement
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -
Acronym
Study on the Effects of Test Food Intake on Skin Function Improvement
Scientific Title
Study on the Effects of Test Food Intake on Skin Function Improvement
- Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial -
Scientific Title:Acronym
Study on the Effects of Test Food Intake on Skin Function Improvement
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of consuming the test food on skin function and to confirm its safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin moisture-related indicators at the 8-week post-intervention examination
Key secondary outcomes
*Secondary Evaluation Items
1) Skin-related indicators at the 8-week post-intervention examination
a. Skin viscoelasticity
b. Collagen score
c. VISIA facial image analysis
d. Visual assessment by a specialist physician
e. Perceived VAS questionnaire
*Safety Evaluation Items
1) Physical Examination (Blood Pressure/Pulse Rate, Weight/Body Fat Percentage/BMI)
2) Daily Activity Log
3) Physician Consultation and Adverse Event Investigation
*Other Items
1) The Fitzpatrick Skin-Type
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test food A: 2 packets once daily for 8 weeks
Interventions/Control_2
Test food B: 2 packets once daily for 8 weeks
Interventions/Control_3
Placebo food: 2 packets once daily for 8 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
1) Women aged 35 or older but under 55 at the time of obtaining consent to participate in the trial.
2) Healthy individuals without chronic physical diseases, including skin diseases.
3) Individuals who notice dryness or aging in their skin.
4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
5) Individuals who can attend the designated examination date and undergo the examination.
6) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
Individuals
1) currently suffering from any disease and undergoing drug therapy.
2) undergoing hormone replacement therapy.
3) with symptoms of skin diseases such as atopic dermatitis.
4) who have taken or applied drugs for disease treatment within the past month.
5) with a history or current condition of severe disorders affecting the digestive organs, liver, kidneys, heart, lungs, blood, or mental health.
6) with a BMI of 30.0 kg/m2 or higher.
7) who may have allergic reactions to test food components, or severe allergies to other foods or medications.
8) who currently, or within the past 3 months, have regularly consumed foods or supplements claiming skin improvement and containing ingredients that may affect the results.
9) with a habit of consuming natto or green juice.
10) whose average daily alcohol intake exceeds 20 g of pure alcohol per day.
11) with a smoking habit.
12) who may work night shifts or change their lifestyle habits during the trial period.
13) who may experience symptoms such as itching at the evaluation site during the trial period due to seasonal allergies like hay fever. Also, individuals who may take anti-allergy medications or use nasal sprays.
14) who cannot avoid intentional exposure to direct sunlight, such as sunbathing, during the trial period.
15) who have undergone cosmetic procedures or treatments on the evaluation site within the past 6 months, such as aesthetic treatments or hyaluronic acid injections.
16) with wounds or inflammation at the evaluation site, or those who expect test-affecting skin irritation at the site around menstruation.
17) who are pregnant, breastfeeding, or at risk of becoming pregnant during the trial period.
18) currently participating in another human clinical trial, or those who completed another trial within the past 3 months.
19) Other individuals deemed unsuitable for this trial by the principal investigator.
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Asari |
Organization
J-OIL MILLS, Inc.
Division name
Health Materials Group Overseas Business Development Department
Zip code
104-0044
Address
St. Luke's Tower, 8-1 Akashi-cho, Chuo-ku, Tokyo
TEL
03-5148-7100
hikaru.asari@j-oil.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
J-OIL MILLS, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069157
